Resources

Operations Manual — The University of Michigan Human Research Protection Program Operations Manual (OM) is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and other members of the research community.

Standard Operating Procedures — The Institutional Review Boards of the University of Michigan Medical School Standard Operating Procedures (SOPs) serve as the overarching guidelines for IRBMED practices and procedures.

Glossary — The IRBMED Glossary is a compilation of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources.  (Added 4.10.2012)

Simplification Guide to Medical Terms — The Simplification Guide can be used to choose different words or phrases more able to be understood by a lay-person.  (Added 6.8.2012)

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Guidance

To find guidance on a particular topic, you may either click on one of the following letters or scroll down through the alphabetical listing.

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

 

A  
Accessing Medical Records   Advertising (see Recruitment Advertising)
Adverse Event Definitions (Added 3/20/2012)   Amendments: Routine or Urgent
Adverse Event Reporting   Assent (see Children - Assent)
B  
Belmont Report--Ethical Principles   Blood Draw Guidelines
Blinded Studies  
C  
Certification Preparatory to Research   Complaints from Subject or Others about a Research Study
Certificate of Confidentiality Kiosk (NIH website)   Compliance Office
Children in Research   Concealment
Clinical Research Calendar Review & Analysis Office (CRAO)   Consent (see Informed Consent)
ClinicalTrials.gov: Registration   Covered Entity
ClinicalTrials.gov: UM Policy  
D  
Data Safety Monitoring Boards: Agency for Healthcare Research and Quality (AHRQ) Mandatory Use   Deception
Decedents   De-Identified Data Sets
E  
Eligibility Screening   Emergency Research with Exception from Informed Consent: FDA Guidance
Emergency Use of Test Articles   eResearch
Emergency use of a Humanitarian Use Device see the HUD Guidance   Exempt Research
Emergency Research with Exception from Informed Consent   Expedited Review
F  
Federal Regulations   Fetuses
Fees for IRBMED Review   Foster children (see Wards of state)
G  
Genetic and DNA Based Research    
H  
HIPAA Guidance   Humanitarian Use Device (HUD) Guidance
I  
iFeasible   International Research
Informed Consent   Investigator Responsibilities
J  
     
K  
     
L  
Limited Data Sets    
M  
Medical Records Access   Minors in Research
N  
Neonates    
O  
Operations Manual (OM)   Other Reportable Events and Information (ORIO Reporting)
P  
Payment to Research Subjects   Protected Health Information
Prisoners in Research   Protocol Deviations, Exceptions, Violations
Privacy Board    
R  
Radiation Exposure Guide   Removal of Blood
Reconsenting Study Subjects   Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA)
Record Retention--How Long to Keep Research Records   Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
Recruitment/Advertising    
S  
Standard Operating Procedures (IRBMED)    
T  
Telephonic Consent   Test Articles in Research
U  
Umclinicalstudies.org (formally Engage)   Urgent Amendments
Unanticipated Problems involving research subjects or others    
V  
Vulnerable Populations    
W  
Waiver of HIPAA Authorization Request   Wards of the State as Research Subjects
X  
     
Y  
     
Z  
     

 

 

Updated 3/6/2012